Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both premarket submissions and life cycle management considerations, the more important consideration is that the FDA’s centers for devices, drugs and biologics have all signed off on the draft, suggesting an agency-wide convergence in thinking about AI.
It was in with the new and out with the old Jan. 3 as the gavel came down on the first session of the 119th U.S. Congress. Although Republicans will control both the House and Senate for the next two years, their narrow majority could prove a challenge to passing some of President-elect Donald Trump’s agenda, including his proposal to cut the corporate tax rate to 15% for companies that manufacture their products in the U.S.
Psychedelic drugs continued to make regulatory and clinical headway, as non-believers converted to believers in the category once regarded with skepticism, to say the least.
Zhongzhi Pharmaceutical Holdings Ltd. made a $3 million investment in a series A financing round of stem cell therapy developer Gabaeron Inc. Dec. 21, expected to help propel Gabaeron’s preclinical Alzheimer’s disease (AD) candidate into phase I testing.
As investors and industry alike try to read the tea leaves of what the upcoming change in administrations holds for the U.S., speculation abounds about what Trump 2.0 will mean for the biopharma and med-tech spaces.
The device industry is extraordinarily dependent on administrative activity where Medicare coverage is concerned, and this was exceptionally evident in 2024 when software and digital health coverage policies remained bogged down.
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
Rounding out a year of insider trading charges involving biopharma companies, the U.S. SEC reported Dec. 30 that it had filed a complaint against two top Humanigen Inc. executives, Cameron Durrant, CEO, and Dale Chappell, chief science officer,
for trades based on insider knowledge of FDA actions.
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
Ausperbio Therapeutics Inc. raised $110 million from two financing rounds in 2024 to advance its lead antisense oligonucleotide candidate as a functional cure for chronic hepatitis B.
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